Regulatory and Validation Quality Associate

One of our clients in the region of Antwerp (West) is looking for a motivated Regulatory and Validation Quality Associate.

  • Do you have a master's degree in life sciences and two years of experience in the pharmaceutical industry (or equivalent by acquiring a PhD)? 
  • Do you have a fluent knowledge of both Dutch and English?
  • Are you interested in the world of validation, regulatory and quality?

Did you say yes to all previous questions? Don't hesitate to contact us and send your CV!

Job Description 

Our client has an impressive portfolio of new drugs approaching commercial launch.
The Regulatory and Validation Department is therefore seeking a dynamic Regulatory and Validation Quality Associate to join our team to support the commercial launch of new drug products.  

In this role you will be the quality reviewer of validation and will support new product registration activities of the assigned products. 
You will work in cross-functional teams and collaborate with external parties including R&D and Global Chemistry, Manufacturing & Controls (GCMC) colleagues in order to support the introduction of new products in the site.
Are you seeking to work with innovative products, in an exciting and fast evolving environment? Join our team!

Responsibilities 
You will be quality authority for process validation and underlying product-related validations such as analytical method, filtration, primary packaging and raw material validations.
You will assist in coordinating the implementation of new products in the plant, e.g. the product flow, the testing protocols, release process etc.
You will work closely with subject matter experts in the manufacturing site and GCMC colleagues to  support regulatory submissions of the new products.
 
Profile 

Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..) 

Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD),  with experience or interest in validation, regulatory and quality

Specific skills:

  • Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
  • Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset
  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills
  • Insight and understanding of stakeholders’ needs and requirements
  • Dynamic, flexible, enthusiastic and eager to learn 
  • Takes initiative and ownership to deliver on time without compromising on quality 
  • Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation) 
  • Fluent in written and spoken English and Dutch
Contact Information 

Anneleen De Vos
Anneleen.devos@valesta.com
015 21 11 04

Application form : Regulatory and Validation Quality Associate

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